Skip to the page
Get started – free

Data / Medical devices / Infusion Safety Management Software

Infusion Safety Management Software (PHC): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make Infusion Safety Management Software (product code PHC, Class 2, 21 CFR 880.5725). 5 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on April 2, 2026, and lists 11 recall events (4 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
PHC
Device class
2
Regulation
880.5725
Medical specialty
General Hospital

Makers by country

CountryMakers
United States9
Mexico2
India1
France1
Dominican Republic1
Costa Rica1

Makers of Infusion Safety Management Software

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer4April 2, 2026030api.fda.gov
Icu Medical, Inc.San Diego, CA, United StatesManufacturer, Specification developer3April 2, 2026000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Manufacturer, Specification developer1March 29, 2024000api.fda.gov
Baxter Innovations & Business Solutions Pvt. Ltd.Bangalore Karnataka, IndiaSpecification developer1March 29, 2024000api.fda.gov
Fresenius Vial S.A.S.Brezins Isere, FranceManufacturer1March 1, 2022000api.fda.gov
Baxter Healthcare CorporationMedina, NY, United StatesManufacturer, Specification developer0010api.fda.gov
CareFusion 303, INCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
CareFusion 303, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0021api.fda.gov
Fenwal International, Inc.HAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Fresenius Kabi USA, LLCNorth Andover, MA, United StatesManufacturer, Specification developer0021api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
ICU Medical Costa Rica Ltd.La Aurora de Heredia, Costa RicaManufacturer0000api.fda.gov
Intego Software, LLC D/B/A Critical AlertJacksonville, FL, United StatesManufacturer0000api.fda.gov
Sistemas Medicos Alaris S.A de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov

Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.